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Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00045877
Enrollment
Unknown
Registered
2002-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2006-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Non-Hodgkin

Keywords

Low-Grade or Follicular Non-Hodgkin's Lymphoma

Brief summary

The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.

Interventions

Sponsors

Chiron Corporation
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis and disease status: * Subjects with CD20+, B-cell, Non-Hodgkin's lymphoma of low-grade or follicular histology with measurable relapsed or unresponsive disease after prior therapy; mantle cell and chronic lymphocytic leukemia subtypes are excluded. * Subjects who previously received a single-agent course of rituximab and showed no tumor response, or had a response lasting \< 6 months. The previously administered rituximab must have included at least 75% of the standard 4-week regimen (4 x 375 mg/m2). A record of the previous rituximab treatment and response must be available as a source document at the site. Exclusion: * Subjects who showed no tumor response or a response lasting \<6 months to treatment with Rituximab in combination with Chemotherapy or another therapeutic modality (radiation or radioimmunoconjugates). * HIV positive. * Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism. * Clinically significant cardiac, pulmonary, and /or hepatic dysfunction (if subject has history of congestive heart failure or myocardial infarction, must have been stable for at least 6 months, and have no current symptoms * If cardiac ejection fraction has been measured, it must be greater than 50%.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026